FDA Approves Exaglo

ST. LOUIS--(BUSINESS WIRE)--Mar 2, 2010 - Covidien today announced that the U.S. Food and Drug Administration (FDA)
has approved the New Drug Application 21-217 for Exalgo
(hydromorphone HCl) Extended-Release Tablets, (CII).

The indication for Exalgo is once daily administration for the
management of moderate to severe pain in opioid-tolerant patients
requiring continuous, around-the-clock opioid analgesia for an
extended period of time.

Currently, many people suffer from moderate to severe chronic
pain such as low-back pain, even with the medications that are
already available. In fact, physicians frequently try many types of
opioids before finding a regimen that provides adequate pain relief
for a patient. Exalgo tablets provide a well known therapy in
hydromorphone HCl, which has been used in the treatment of chronic
pain for more than 80 years – now in an extended-release
formulation. FDA approval of Exalgo tablets offers an important new
treatment for physicians treating opioid-tolerant patients for
moderate to severe chronic pain.

Exalgo utilizes the OROS® Push-Pull
osmotic delivery system designed to release the opioid at a
controlled rate. By providing a steady release of hydromorphone
throughout the day, the drug is formulated to help minimize the
peaks and troughs that are sometimes experienced by chronic pain
patients who rely on products that are dosed at more frequent
intervals.

Covidien is the largest supplier of controlled pain medications
in the United States based on number of prescriptions. Its
development partner, CombinatoRx, Incorporated, develops novel drug
candidates with a focus on the treatment of pain and
inflammation.

"We are excited that our collaboration with CombinatoRx
provides physicians and patients with the only extended-release
hydromorophone treatment that will be available for this type of
pain relief," said Timothy R. Wright, President,
Pharmaceuticals, Covidien. "Building on more than a century
of pain treatment experience, Covidien is focused on providing
patients with access to advanced medications that expand the limits
of pain therapy by combining proven drugs with innovative delivery
systems.

In June 2009, the companies announced that Mallinckrodt Inc., a
Covidien company, had entered into an asset purchase agreement with
Neuromed for the U.S. commercialization rights to Exalgo. Under the
agreement, Covidien is responsible for all commercialization
activities for Exalgo, including marketing, sales and all
post-approval FDA regulatory filings.

"Reflecting our commitment to pain management, we will be
significantly increasing our branded pharmaceutical sales force in
2010 as a result of the approval of Exalgo," said Wright.

The launch of Exalgo tablets, which Covidien anticipates in the
first half of calendar year 2010, will include a comprehensive Risk
Evaluation and Mitigation Strategy (REMS) that is designed to
ensure that the benefits of Exalgo outweigh the potential risks.
The REMS for Exalgo includes a medication guide and a robust set of
educational programs and materials as part of the company's focused
effort to help ensure that prescribers, pharmacists and patients
have the needed information regarding appropriate prescribing,
dispensing and use of Exalgo tablets. Under the program, healthcare
provider education is required as an important element to assure
safe use with a focus on appropriate patient selection and dosing.
As part of Covidien's ongoing commitment to be a responsible
advocate for patients, the company has also voluntarily developed a
broad range of safe use tools for Exalgo that will be provided to
healthcare professionals, pharmacists, patients and caregivers and
will be continually reviewed for improvement.

PLEASE SEE IMPORTANT RISK INFORMATION, INCLUDING BOXED
WARNING BELOW

Exalgo is contraindicated in opioid non-tolerant patients, in
management of mild pain or pain not expected to persist, in
patients with compromised respiratory function or in patients with
narrowed or obstructed gastrointestinal tract or with known
hypersensitivity to any components including hydromorphone
hydrochloride and sulfites. Concurrent use of Exalgo with CNS
depressants, including alcohol, increases risk of respiratory
depression, hypotension, and profound sedation, potentially
resulting in coma or death. Not recommended in patients who have
received MAO inhibitors within 14 days of starting Exalgo.

See full package insert for full prescribing information.

WARNING: POTENTIAL FOR ABUSE, IMPORTANCE
OF PROPER PATIENTSELECTION AND LIMITATIONS OF USE

Potential for Abuse

Exalgo contains hydromorphone, an opioid agonist and a
Schedule II controlled substance with an abuse liability similar to
other opioid analgesics. Exalgo can be abused in a manner similar
to other opioid agonists, legal or illicit. These risks should be
considered when administering, prescribing, or dispensing Exalgo in
situations where the healthcare professional is concerned about
increased risk of misuse, abuse, or diversion. Schedule II opioid
substances which include hydromorphone, morphine, oxycodone,
fentanyl, oxymorphone and methadone have the highest potential for
abuse and risk of fatal overdose due to respiratory depression
[see Drug Abuse and Dependence (9)].

Proper Patient Selection

Exalgo is an extended-release formulation of hydromorphone
hydrochloride indicated for the management of moderate to severe
pain in opioid tolerant patients when a continuous around-the-clock
opioid analgesic is needed for an extended period of time. Patients
considered opioid tolerant are those who are taking at least 60 mg
oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg of
oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg of oral
oxymorphone/day or an equianalgesic dose of another opioid, for a
week or longer [see Indications and Usage (1) and Dosage and
Administration (2)].

Exalgo is for use in opioid tolerant patients only [see
Indications and Usage (1) and Dosage and Administration (2)].

Fatal respiratory depression could occur in patients who are
not opioid tolerant.

Accidental consumption of Exalgo, especially in children, can
result in a fatal overdose of hydromorphone [see Warnings and
Precautions (5.1)].

Limitations of Use

Exalgo is not indicated for the management of acute or
postoperative pain [see Indications and Usage (1)].

Exalgo is not intended for use as an as needed analgesic
[see Indications and Usage (1)].

Exalgo tablets are to be swallowed whole and are not to be
broken, chewed, dissolved,

crushed or injected. Taking broken, chewed, dissolved or
crushed Exalgo or its contents leads to rapid release and
absorption of a potentially fatal dose of hydromorphone [seeWarnings and Precautions (5)].

OROS® and Push-Pull™ are trademarks of ALZA
Corporation.

About Covidien

Covidien is a leading global healthcare products company that
creates innovative medical solutions for better patient outcomes
and delivers value through clinical leadership and excellence.
Covidien manufactures, distributes and services a diverse range of
industry-leading product lines in three segments: Medical Devices,
Pharmaceuticals and Medical Supplies. With 2009 revenue of $10.7
billion, Covidien has 42,000 employees worldwide in more than 60
countries, and its products are sold in over 140 countries. Please
visit
www.covidien.com to learn more about our business.

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